Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix.

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this phase II study is to determine the survival free disease of patients diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive chemoradiation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

1. Advanced carcinoma of uterine cervix histological confirmed.

2. Indication for definitive chemoradiation treatment;

3. Measurable disease by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria;

4. Age between 18 years old and 70 years old;

5. Adequate bone marrow and organ function defined by laboratory values;

6. Non evidence of disease in para-aortic lymph node;

Exclusion Criteria:

1. Previous treatment with Chemotherapy or radiotherapy

2. Previous surgery for primary tumor;

3. Distant metastasis;

4. Performance status according to Eastern Cooperative Oncology Group greater than 2;

5. Peripheric neuropathy greater than grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 3.0;

6. Significant Cardiac disease (history of and/or active disease);

7. Other treatment for cancer, including hormonotherapy;

8. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements;